Durect announced Thursday that the FDA accepted its marketing application for the surgical pain drug Posidur (bupivacaine) for review. Posidur, a single injection that uses Durect's SABER technology, is designed to provide up to three days of postsurgical pain relief. The company indicated that the FDA will complete its review of the application by February 12 next year.
CEO James Brown remarked that "treating post-surgical pain with a true, long-acting local anaesthetic has the potential benefit of reducing the need for opioids and their associated systemic side effects." Shares of Durect rose more than 10 percent on the news.
Durect added that it is holding discussions with potential partners concerning the licensing and commercialisation rights for Posidur. In 2010, Durect entered into a development and commercialisation agreement with Hospira that gave the latter exclusive marketing rights to Posidur in the US and Canada following regulatory approval, but Hospira returned these rights to Durect in March 2012.
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